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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K161120
Device Name SMR TT Metal Back Glenoid, Bone Graft instruments
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact Emanuele Buttazzoni
Correspondent
Peoples & Associates Consulting, LLC
5010 Lodge Pole Ln.
Fort Wayne,  IN  46814
Correspondent Contact Stephen Peoples
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT  
Date Received04/21/2016
Decision Date 02/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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